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Abbott Regent Mechanical Heart Valve Sizer Set - HSA Registration DE0508390

Access comprehensive regulatory information for Abbott Regent Mechanical Heart Valve Sizer Set in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508390 and owned by Abbott Medical. The device was registered on August 16, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0508390
Abbott Regent Mechanical Heart Valve Sizer Set
HSA Registration Number: DE0508390
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Product Description

The Regent Mechanical Heart Valve Sizer Set Model 907 is a kit comprised of multiple sizing tools that facilitate proper handling and implant size selection of the Regent Mechanical Heart Valve.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0508390
Registration Date
August 16, 2023
Change Notification Approval Date
December 22, 2023
Retention Due Date
August 15, 2025
Product Owner
Short Name
Abbott Medical
Address
177 County Road B East, St. Paul, Minnesota 55117, UNITED STATES
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
Valve Holder Handle Regent Mechanical Heart Valve Sizer Set
Model Identifier(s)
905-HH 907